Barrier device

ABSTRACT

The device, for use in contraception and in preventing transmission of sexually transmitted diseases, comprises a thin, flexible pouch having an open end in the form of a peripheral flange with a peripheral ribbed rim, and a closed end. An insert is provided within the closed end of the pouch so as to protect the pouch during insertion thereof into the vagina by means of an applicator rod or the like. The insert, which is typically absorbent and of flexible expanded plastics material, and may have dispersed therein a spermicide and/or an antiviral agent, comprises a central portion and four spurs. A continuous coating layer of an adhesive material which can temporarily adhere the barrier device to mucous membrane material in the presence of aqueous body fluids is preferably provided on the vulva-contacting surface of the flange and/or on the vagina-contacting surface of the pouch.

This application is a continuation of application Ser. No. 08/025,388filed on Mar. 2, 1993, abandoned which was a continuation of applicationSer. No. 07/640,371, filed as PCT/GB89/00726, Jun. 29, 1989 now U.S.Pat. No. 5,193,555.

The present invention is concerned with barrier devices for use incontraception and in preventing transmission of sexually transmitteddiseases.

It is known that barrier-type contraceptive devices ("condoms") areeffective not only as contraceptives, but also to help prevent sexualtransmission of diseases. Indeed the use of a condom Is positivelyrecommended as a prophylactic measure against, in particular, acquiredimmune deficiency syndrome (AIDS).

Condoms have, traditionally, been only suitable for use by the malepartner; they can only be donned on an erect penis, immediately beforeintercourse. This has been found to be off-putting by many users and theresulting delay can sometimes lead to loss of erection by the male;furthermore, the traditional male condom permits contact between vaginalmucous membranes and the penis at the entrance to the vagina, withconsequent risk of disease transmission. The male condom may becomedislodged under certain circumstances during intercourse (e.g. on lossof erection or withdrawal of the penis), with consequent failure of thecontraceptive and disease-preventing barrier.

In order to alleviate these disadvantages and provide an alternativemeans of contraception and prevention of sexual transmission ofdiseases, the so-called "female condom" has been developed. One such"female condom" (as described in our PCI Patent Application GB88/00042)is a barrier device which comprises a continuous, liquid-impermeableshield member shaped and dimensioned so that, in its operationalposition, it covers the entrance of a user's vagina, the shield memberhaving integral therewith a continuous liquid-impermeable flexible poucharranged to be introduced into the vagina so as to form a liquid barrierbetween the penis and the vagina; and means for securing the shieldmember in the operational position.

We have now devised an improvement in such barrier devices, which can besuitable for use either as female condoms or as male condoms.

According to a first aspect of the present invention, therefore, thereis provided a barrier device comprising a continuous,liquid-impermeable, flexible pouch having an open end and a closed endsuch that the pouch can form a liquid barrier between a penis and avagina; and a soft resilient insert arranged for insertion in said pouchbetween the tip of the penis and said closed end, said insert comprisinga generally central portion and, extending outwardly from said centralportion, means for biassing said pouch in the vicinity of said closedend into contact with the walls of the vagina.

According to a second aspect of the present invention, there is provideda barrier device comprising a continuous, liquid-impermeable, flexiblepouch having an open end and a closed end such that the pouch can form aliquid barrier between a penis and a vagina; and a soft absorbentresilient insert arranged for insertion in said pouch between the tip ofthe penis and said closed end, said insert being arranged for biassingsaid pouch in the vicinity of said closed end into contact with thewalls of the vagina.

The resilient insert is such that it facilitates insertion of the pouchinto the vagina, either by means of a separate applicator body, by theuse of a finger or by means of the penis. Alternatively, when the pouchis donned by the male prior to coitus, with the insert located at thetip of the penis, the insert serves to maintain the pouch in positionduring intercourse, and, in some embodiments, after withdrawal of thepenis. In addition to fulfilling these functions, the insert enhancestactile pleasure for the users and (when of absorbent material) mayassist in absorption of sperm.

The resilient insert is typically of flexible expanded polymericmaterial, sponge rubber, solid rubber, plastics or the like; in someembodiments it is, as indicated above, absorbent. The insert typicallycomprises a central body portion and a plurality of radially outwardlyprojecting spurs (such as three or four such spurs). In someembodiments, the body portion has a central depression for receiving thetip of an applicator rod or the like, and three, four or more outwardlyprojecting spurs. The body portion may further comprise a formation onits face remote from the latter depression which is arranged to engagewith a complementary formation (typically in the form of a teat or thelike) provided on the internal surface (that is, the penis-contactingsurface) of the pouch, such that the insert is retained in position whenthe pouch is inserted in the vagina. Typically, the formation on thebody portion comprises a protrusion and the complementary formation onthe internal surface of the pouch comprises a depression capable ofreceiving the protrusion. Alternatively, the resilient insert may beretained in position by an adhesive coating on the insert and/or on theinternal surface of the pouch.

It is preferred in some embodiments of the invention that the insertshould contain a spermicide and/or a fungicide, bactericide oranti-vital agent, which is such that it is slowly released in situ.Certain embodiments of the barrier device according to the invention aresuitable for use as male condoms; further embodiments are suitable foruse as female condoms; and still further embodiments are suitable foruse as either, according to choice.

When the device is intended for use as a female condom, the open end ofthe pouch preferably has, integral therewith, a continuousliquid-impermeable peripheral flange arranged to cover the vulva (aroundthe periphery of vaginal entrance). In this case, the barrier device maybe employed together with an elongate applicator body (in the form of arod or the like) which is arranged to introduce the pouch into thevagina and be withdrawn therefrom, so as to leave the pouch in place.When the applicator body is thus withdrawn, the biassing means acts toretain the pouch in place in the vagina.

It is preferred that such a peripheral flange should have bonded theretoon the vulva-contacting surface and/or on the vagina contacting surfacea continuous coating layer of an adhesive material which is such that itcan temporarily adhere the surface to mucous membrane material in thepresence of aqueous body fluids.

The use of such a coating layer is believed to be novel per se; thepresent invention therefore further comprises a barrier devicecomprising a continuous liquid-impermeable shield member shaped anddimensioned so that, in its operational position, it substantiallycovers a user's vulva, the shield member having integral therewith acontinuous liquid-impermeable flexible pouch arranged to be introducedinto the user's vagina so as to form a liquid barrier during coitusbetween the vagina and the penis; and means for securing the shieldmember in the operational position, in which the vulva-contactingsurface of the shield member and/or the vagina-contacting surface of thepouch has bonded thereto a substantially continuous coating layer of anadhesive material which is such that it can temporarily adhere saidbarrier device to mucous membrane material in the presence of aqueousbody fluids.

An example of a preferred adhesive material is a hydrogel-type material,which is preferably a hydrophilic synthetic polymer. Examples ofsuitable such polymers are polymers of vinyl pyrrolidone, hydroxyalkylacrylates or methacrylates, of an acrylamide; such polymers generallyhave (in addition to temporary adhesive properties for holding thedevice in place in the vagina), lubricating properties.

Such an adhesive coating layer or layers preferably contains, inaddition to a hydrophilic polymer vehicle, a physiologically acceptablefungicide and/or bactericide, and, most preferably, a spermicide. It isparticularly preferred to incorporate a spermicide, such as anethoxylated alcohol (for example, the material commercially availableunder the trade mark "Nonoxinol" which is also believed to haveanti-viral properties) in the coating layer.

In a further preferred embodiment of the invention, the internal surface(that is, the penis-contacting surface) of the device according to theinvention is itself provided with a preformed coating layer havinglubricating properties; an example of a suitable type of coating layeris a layer comprising a hydrogel polymer as described above.

The sheath may be of any suitable rubber or plastics material; by way ofexample, the sheath may be of dipped rubber (of, for example, naturalrubber), polyurethane or the like. It is preferred that the sheath andthe shield member should together constitute a seamless unitary body.

The present invention further comprises a modification of the femalecondom device Just described, which comprises a device for use by eithera male or female user in which the pouch is arranged to be introducedinto the anal passage of the user. In this modification of theinvention, the peripheral flange is arranged to cover the periphery ofthe anal passage, and all references herein to "vagina" and "vaginalwalls" are, when relevant to this embodiment, to be construed asrespectively reference to the anal passage and the walls thereof.

A preferred embodiment of the present invention will now be describedwith reference to the accompanying drawings, in which:

FIG. 1 is a longitudinal sectional view of an exemplary barrier deviceaccording to the invention, together with an applicator therefor;

FIG. 2 is a plan view of an insert for a barrier device such as thatshown in FIG. 1;

FIG. 3 is a sectional view along line A--A in FIG. 2; and

FIG. 4 is a longitudinal section of the device of FIG. 1 when in theprocess of being inserted into the user's vagina by means of anapplicator.

Referring to FIG. 1, there is shown a barrier device in the form of athin, flexible pouch 1 having an open end 2 in the form of a peripheralflange with a peripheral ribbed rim 3, and a closed end 4, the portionof the pouch between the open and closed ends being folded in uponitself within an applicator body 11. The closed end 4 has a teat-likeprojection 5 (with a corresponding recess in the internal surfacethereof).

The applicator body 11 is in the form of an inwardly tapering tube,tapering from a flanged end 12 to a narrowed end 13; integral with theflanged end 12 is a further tapering tubular portion 14, taperinginwardly in the direction leading away from narrowed end 13. Taperingportion 14 terminates with 8 generally cylindrical portion, whichengages with the external surface of an applicator rod 15 having agripping portion 15a and a portion 15b which is to be inserted into theapplicator body; the latter portion is of reduced diameter relative tothe gripping portion and connected thereto by a tapered shoulder 21. Theconnection 22 between the shoulder 21 and portion 15b is of slightlyincreased diameter, so as to inhibit inadvertent withdrawal of theapplicator rod from the applicator body. The tip 16 of the end portion15b (which is typically part-spherical) engages with insert 17 withinthe closed end 4 of barrier device; the insert acts to protect thematerial of the pouch during insertion thereof into the vagina by meansof the applicator cod 15.

Referring to FIGS. 2 and 3, the insert 17, which is typically offlexible expanded plastics material having dispersed therein aspermicide and/or an antiviral agent, comprises a central portion 18having a generally part-spherical recess 19 (shaped to receive the tip16 of applicator rod 15), and (extending radially outwardly from centralportion 18) four spurs 20a, 20b, 20c, 20d. The obverse of centralportion 18 has a button-like projection 10 capable of engaging therecess in the internal surface of the closed end 4 of pouch 1 (see FIG.4).

In operation, as illustrated in FIG. 4, the pouch 1 and the applicatorbody 11 are together inserted into the user's vagina in the orientationshown in FIG. 1; applicator cod 15 is then pushed manually in thedirection of arrow B so as to extend the pouch to its fullest extentwithin the vagina, to the orientation shown in FIG. 4. The projection 10engages the closed end of the pouch 1 so that the insect 17 is correctlylocated. When the cod has been fully inserted, the spurs 20a, 20b, 20c,20d open out to cause the closed end 4 of the pouch to engage with thevaginal walls 30; the applicator cod 15 and the applicator body 11 arethen withdrawn, leaving the pouch in place with the open end 2 incontact with the vulva 31.

The open end 2 of the pouch may be provided with an adhesive coating ofthe type described above on the vulva-contacting surface.

We claim:
 1. A barrier device comprising:a continuous,liquid-impermeable, flexible pouch having an open end, a closed end, anda diameter, said diameter being sufficiently large to permit movement ofa penis within said pouch, said pouch forms a liquid barrier membranehaving a penis-contacting surface and a vagina-contacting surface; and asoft resilient insert for insertion in said pouch between the tip ofsaid penis and said closed end, said insert includes:a generally centralportion-forming spacing member between said tip of said penis and saidclosed end and radially spaced from said central portion; means forbiasing said pouch in a vicinity of said closed end into contact withthe walls of the vagina; and a central depression in said soft resilientinsert, said central depression receives said tip of said penis, whereinsaid soft resilient insert includes a central body portion and aplurality of radially outwardly projectiong spurs.
 2. The barrier deviceaccording to claim 1, wherein there are up to four of said spurs.
 3. Thebarrier device according to claim 2, wherein said central depression insaid soft resilient insert receives an applicator.
 4. The barrier deviceaccording to claim 3, wherein said soft resilient insert furtherincludes a formation on a face remote from said central depression, saidformation being arranged to engage with a complementary formationprovided on said penis-contacting surface of said pouch whereby saidsoft resilient insert is retained in position in said vagina.
 5. Thebarrier device according to claim 4, wherein said formation on said softresilient insert includes a protrusion and said complementary formationon said penis-contacting surface of said pouch includes a depression forreceiving said protrusion.
 6. A barrier device comprising:a continuous,liquid-impermeable, flexible pouch having an open end, a closed end, anda diameter, said diameter being sufficiently large to permit movement ofa penis within said pouch, said pouch forms a liquid barrier membranehaving a penis-contacting surface and a vagina-contacting surface; andasoft resilient insert for insertion in said pouch between the tip ofsaid penis and said closed end, said insert includes: a generallycentral portion-forming spacing member between said tip of said penisand said closed end and radially spaced from said central portion; meansfor biasing said pouch in a vicinity of said closed end into contactwith the walls of the vagina; and a central depression in said softresilient insert, said central depression receives said tip of saidpenis, wherein an adhesive coating is provided on said penis-contactingsurface of said pouch.
 7. A barrier device comprising:a continuous,liquid-impermeable, flexible pouch having an open end, a closed end, anda diameter, said diameter being sufficiently large to permit movement ofa penis within said pouch, said pouch forms a liquid barrier membranehaving a penis-contacting surface and a vagina-contacting surface; and asoft resilient insert for insertion in said pouch between the tip ofsaid penis and said closed end, said insert includes:a generally centralportion-forming spacing member between said tip of said penis and saidclosed end and radially spaced from said central portion; means forbiasing said pouch in a vicinity of said closed end into contact withthe walls of the vagina; and a central depression in said soft resilientinsert, said central depression receives said tip of said penis, whereinsaid oen end of said pouch has, integral therewith, a continuousliquid-impermeable peripheral shield member to cover the vulva.